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Wednesday, June 06, 2007

Avandia Hearing Soap Opera: Ethics, Demagogy, Sensationalism, and Threats by GSK

Almost as soon as Dr. Nissen began his testimony today before Congressman Waxman's Committee on Oversight and Government Reform, he commented that the Committee's work was "clearly the right thing to do."

Rep. Darrell E. Issa (R-California), on the other hand, clearly considered the Committee's work a political circus. Another congressman called it "sensationalism."

But Dr. John B. Buse, a nationally noted diabetes specialist, took center stage with his revelations about how he was treated by GSK several years ago after warning the FDA about Avandia's cardiovaascular problems.

Buse claimed that after he voiced his concerns about Avandia several years ago (1999), a GSK (SmithKline Beecham at the time) employee called him and said the company was upset. He threatened Buse and said he may liable for the multi-billion dollar market de-valuation in GSK stock that his public comments caused.

According to Buse, GSK had a "disturbing" conversation with the chairman of his dept at the University of North Carolina in which GSK characterized Buse as a "liar" and "for sale."

Buse was forced to sign a "clarification" statement, which GSK wrote. He followed up with a "please call off the dogs" letter to GSK.

Waxman later asked a GSK witness -- Moncef Slaoui, Ph.D., Chairman, Research and Development, GlaxoSmithKline -- who threatened Buse. Dr. Slaoui confirmed it was his former boss -- Tachi Yamada -- who is now doing penance at the Gates Foundation.
[For more details on this, see Ed Silverman's informative post "Will Glaxo Sue Steve Nissen For $15 Billion?" in which he points out that Nissen caused much more damage to GSK stock's valuation than Buse ever did!]
Republican committee members repeatedly focused on Nissen's communications with "majority members" of the committee before publication of his NEJM report. Nissen said he spoke to several members in Congress in February, 2007, not just Waxman and his staff.

Waxman clarified that Nissen approached many Congressional committees, but Waxman did not give him any help.

Congressman Issa asked why Nissen didn’t include studies in which no patients had a heart attack, assuming that all those zeros would decrease the significance of Nissen's findings. After he didn't get the response he wanted, Issa rephrased his question to force a yes or no answer which would have forced Nissen to admit that he and Waxman planned on leaving out important data in his meta analysis.

At which point Waxman accused Issa of "demagogy," which wikipedia defines as "a political strategy for obtaining and gaining political power by appealing to the popular prejudices, fears and expectations of the public -- typically via impassioned rhetoric and propaganda, and often using nationalist or populist themes."

Issa was probably appealing to the expectations of the pharma industry rather than those of the general public.

The Sensationalism Issue
Congressman Chris Cannon, Utah (R-Utah) tried to make Nissen cry about all the money pharma companies lose when the public hears bad news about drugs or the industry -- in other words, he thought the messenger, not the message should be blamed.

The congressman, in fact, went all the way back to the Clinton era to make his point -- which seems to be "loose lips sink drug ships."

"Do you have a concern about drug stock devaluation in reaction to your report?" he asked Nissen.

Nissen stuck to his guns and encouraged everyone to read what he said, because he was very measured and took into account the effect it might have on patients. Besides, said Nissen, "I don't follow waht stocks are doing."

Nissen dismissed the alternative -- not publishing -- as unethical, as if a congressman would relate to such an argument!

Cannon continued his offensive and accused Nissen of creating this sensationalist hearing to "whack" the drug industry.

Mild-mannered Rep. Elijah E. Cummings (D-Maryland)( said "I hate it when witnesses are attacked especially when they are trying to be the best they can be. Putting politics over the health of the American people bothers me," he said.

When Buse finally got a chance to respond to Issa's warped questioning tactics, he pointed out that everyone, including GSK, is getting the same response when they do meta analyses, no matter what data they include. "You cannot get any data from trials where there is no data, no matter how logical it may seem," he said.

Issa claimed that Nissen's analysis is biased because it left out data from trials with no heart data. He thought that science still needs to work on it. Sounds to me that Issa needs some work to do on understanding the scientific method.

Waxman concluded: "If FDA and GSK had listened to you [Buse] 7 years ago, we would have had a more definitive answer than we have today."

1 comment:

  1. Did anyone point out at any time that the NEJM published the study, NOT Nissen??? Nissen did the study, but the NEJM CHOSE to publish it, after their editors deemed to worthy.

    So now Nissen should be penalized for doing a meta analysis?????

    I dont agree with his conclusions, but again Congress, a body totally incapable of interpreting medical facts (Terry Schiavo, anyone?) is attempting to manipulate their position for presumably unscrupulous gain (i.e. campaign contributions and lucrative jobs after retiring from "public service")

    Disgraceful!

    ReplyDelete

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